Is Kratom a Public Health Threat or a Promising Herb in Need of More Research?

The process to determine the future of kratom( Mitragyna speciosa ), an herb native to Southeast Asia thatas generated regulatory controversy over the past few months, entered a new stage last week. On December 1, specific comments period closed for the public to respond to the Drug Enforcement Agencyas( DEA) proposal to classify two constituents of the kratom plant into schedule 1 of the Controlled Substances Act( CSA ). And while some leaders of the natural products industry supported the DEAas proposed action against the plant, others recommended relevant agencies to reconsider.

Kratomas Rocky Past

Kratom has built numerous headlines over the past few months, beginning with the DEAas announcement on August 31 that it intended to classify two psychoactive constituents of kratom( mitragynine and 7-hydroxymitragynine) into schedule 1. But itas not the first regulatory speed bump for the plant. In 2014, FDA banned import of the herb into the United States, and relevant agencies has written that there adoes not appear to be a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient.a In particular, FDA expressed concerns that kratom intake can lead to negative health outcomes, including respiratory depression, hallucinations, nausea, and more.

The DEA pointed to many of the same health risks in its August announcement, calling the plant an aimminent hazard to public safety.a Much of kratomas popularity stems from its opioid-like effects that some experts say help prescription opioid users wean themselves off their cravings. But as a result of those effects, the DEA tells, kratom ahas a high potential for abuse.a The bureau proposed it would place its two main psychoactive constituents into schedule 1 under the CSAas temporary scheduling provisions, which would effectively place the whole kratom plant on the same list of banned substances as heroin and LSD.

That move was ultimately delayed following a creek of letters from industry stakeholders and congressional leaders urging the DEA to follow a regular review process allowing for the public to remark. The DEA then announces that it would no longer seek its emergency listing, but would instead open a public remark period objective on December 1.

Industry Response

With specific comments period now closed, itas evident that leaders within the natural products industry are taking very different approaches to the DEAas proposed action against kratom. To start with those in agreement with the DEA, Dan Fabricant, CEO and executive director of the Natural Product Industry( NPA; Washington, DC ), called out kratom as a athreat to public health.a

aAdding an untested and unregulated substance such as kratom to our food supply without the application of longstanding federal rules and guidelines would not only be illegal, it could likely be dangerous, to move to serious unintended repercussions as our nation fights with the crisis of opioid craving, a Fabricant said in NPAas formal remarks submitted to the DEA . He added that kratom has never been submitted as a New Dietary Ingredient( NDI) notification to FDA, and that NPA welcomes DEAas proposal to classify kratom into schedule I as a anecessary and welcome first step.a

But other industry associations, including the American Herbal Product Association( AHPA; Silver Spring, MD) and the American Botanical Council( ABC; Austin, TX ), recommended the DEA to reconsider its position. For instance, Michael McGuffin, chairwoman of AHPA, cautioned that it would be an aabuse of discretiona for the DEA to use its scheduling authority to remove an herbal plant from the existing marketplace just because one or more of its naturally occurring constituents have become subject to scheduling under the abroad standardsa of the CSA. Such a move would also have a detrimental effect on research into kratomas benefits, McGuffin said.

a AHPA believes restrictions on research are contrary to the interests of science and ultimately detrimental to the public interest, a McGuffin told. a AHPA members want to ensure that any process that proposes to classify a naturally occurring constituent of a plant as an illicit substance includes a thorough evaluation of available scientific data and full consideration of potential risks and benefits of eating the substance.a

Meanwhile, ABC also called on the DEA to not proceed with its arestrictive schedulinga of kratom, and pointed to a recently published article in its HerbalGram exploring the various issues related to the use of kratom. ABCas remarks to the DEA also called attention to the body of proof supporting kratomas possible benefits, including its potential to alleviate opioid-withdrawal symptoms. And while further research is necessary to understand both kratomas potential benefits and safety issues, categorizing the plant into schedule 1 was able to make such research attempts more difficult, ABC explained.

a ABC realizes that there are obliging scientific data to support kratomas potential therapeutic utilize; there is also embarrassment about its safety profile, a told Mark Blumenthal, founder and executive director of ABC, in a press announcement. aOur remarks to DEA are intended to help ensure that appropriate scientific and medical research on this interesting plant and its biologically active constituents can continue with minimal regulatory hurdles.a

ABC also noted that it supports existing FDA enforcement actions against kratom products on the market that are not of complying with FDA regulations.